MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE COBRA SUTURE PASSER, CAPTURE; ACCESSORIES, ARTHROSCOPIC

Model Number 3910900093

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that the needle broke during procedure.All pieces were retrieved.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

Through the investigation it was confirmed that the needle did not actually break, as it got stuck in the jaw and bent, therefore making this event not reportable.Please note that the initial report's type of reportable event was that "it was reported that the needle broke during procedure.All pieces were retrieved.".

Manufacturer Narrative

Through the investigation it was confirmed that the needle did not actually break, as it got stuck in the jaw and bent, therefore making this event not reportable.Please note that the initial report's type of reportable event was that "it was reported that the needle broke during procedure.All pieces were retrieved." alleged failure: eib jared, rep, needle dislodged/broken from bottom jaw.Needle was thrown away.Update: per investigation results, the needle did not actually break.It got stuck in the jaw and bent.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) attempt to use the device with bent needle, 2) use of excessive force, 3) attempt to pass through thick tissue or bone, 4) excessive tissue loaded into jaws, 5) attempt to load or pass incompatible suture, 6) technique error.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: COBRA SUTURE PASSER, CAPTURE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16455946
• MDR Text Key: 310382750
• Report Number: 0002936485-2023-00168
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327413595
• UDI-Public: 07613327413595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3910900093
• Device Catalogue Number: 3910-900-093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1